The Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA) play major roles in regulating drugs, medical devices, ATMPs, etc.
This article summarizes the roles of MHLW and PMDA.
Ministry of Health, Labor and Welfare (MHLW)
The Ministry of Health, Labor and Welfare (MHLW) is responsible for planning and implementing policies as an organization (ministry) of the Japanese government, not limited to regulating drugs, etc. For example, the MHLW is responsible for not only medical care and insurance, but also nursing care and labor, etc.
Within the MHLW, each division of the Pharmaceuticals and Medical Devices Bureau is responsible for policies related to drugs, etc. Discussions such as amendments to the Pharmaceuticals and Medical Devices Act are led by the Pharmaceuticals and Medical Devices Bureau. Various operational notices based on the Pharmaceuticals and Medical Devices Act are issued by the relevant divisions of the MHLW. In addition, the final responsibility on the national side based on the Pharmaceuticals and Medical Devices Act lies with the MHLW.
Other major divisions in the MHLW that are responsible for policies related to drugs, etc. include the Research and Development Policy Division of the Medical Affairs Bureau, the Medical Industry Promotion and Medical Information Planning Division of the Medical Affairs Bureau, and the Medical Affairs Division of the Insurance Bureau.
The Research and Development Policy Division of the Medical Affairs Bureau is responsible for policies related to the promotion of drug development, and is responsible for tasks such as improving the clinical trial environment, securing and distributing research funds related to drugs, etc.
The Medical Industry Promotion and Medical Information Planning Division of the Medical Affairs Bureau is responsible for industry promotion policies centered on drugs. A particularly important role is to act as a liaison office for companies regarding matters related to medical insurance, such as drug price negotiations.
The Medical Affairs Division of the Insurance Bureau is responsible for policies related to medical insurance, such as drug price decision.
The establishment of the Medical Affairs Division of the Insurance Bureau and the Medical Industry Promotion and Medical Information Planning Division of the Medical Affairs Bureau has created an organizational structure in which pharmaceutical companies cannot directly contact the Medical Affairs Division, preventing conflicts of interest and collusion.
Similarly, the Pharmaceutical Affairs Bureau and the Medical Affairs Bureau have separated the roles of regulation and promotion, ensuring an appropriate balance between regulation and promotion of drugs, etc.
Pharmaceuticals and Medical Devices Agency (PMDA)
PMDA is responsible for practical operations centered on scientific discussions based on the Pharmaceuticals and Medical Devices Act and MHLW policies. For example, it is PMDA that actually reviews pre-market application for drugs. Based on the results of PMDA’s reviews, MHLW makes the final decision on approval of the products.
Therefore, company personnel in charge of product development and safety measures mainly communicate with PMDA. PMDA handles pharmaceutical product reviews, receipt and analysis of reports on safety information, investigations related to manufacturing management and quality control, procedures related to clinical trials, and various consultation services.
Summary
The division of roles between the MHLW and the PMDA is that the MHLW is responsible for formulating policies and is ultimately responsible, while the PMDA handles various operations from a scientific perspective. In addition, the PMDA is not in charge of medical insurance (drug pricing)-related matters.
This division of roles is similar to the division of roles between the European Medicines Agency (EMA) and the European Commission (EC) in Europe.
コメント